As most companies selling NHPs in Canada are aware, Health Canada currently takes a risk-based approach to enforcement action against unlicensed NHPs. This does not mean that the sale of such products is legal (and manufacturers should note that the National Association of Pharmacy Regulatory Authorities has urged pharmacists not to carry unlicensed products), but many companies have relied on Health Canada’s position on NHPs to launch their products in Canada. The historical reality is that when the Natural Health Products Regulations (NHPR) came into force, there were already tens of thousands of non-compliant products on the market.
Health Canada has made it clear that its ultimate goal is to end what was intended as a temporary approach to enforcement and move to enforcing the Natural Health Products Regulations (NHPR). The initial objective was to end the current compliance and enforcement policy by December 2010; however, for a variety of reasons, Health Canada decided to postpone this deadline. While Health Canada remains quiet on when this change will occur and how much advance notice will be given, one can reasonably expect that it will not be in the distant future.
In addition to the NHPR, the Natural Health Products (Unprocessed Product Licence Applications) Regulations (UPLAR) came into force on August 4, 2010 as another temporary solution to address the presence of non-compliant NHPs on the market. In short, NHP licence applicants can request that an EN be issued 180 days after their submission of the product licence application. While having an EN makes it legal to sell the product, not all products qualify for an EN and there are time limits within which an EN must be requested.
The UPLAR presents challenges that affect the ability to plan a marketing strategy around a new product. Unlike an actual licence, products with an EN are still under review, which means that Health Canada can reject the NHP licence application at any time, making the EN invalid. Therefore, a company must balance its investment in a new product launch against the risk of a rejection.
The most significant issue with the UPLAR is that it is temporary—a point which many in the industry forget. Section 8 of UPLAR includes language that repeals the UPLAR 30 months after the day it came into force, meaning the UPLAR will be repealed on February 4, 2013.
Assuming that Health Canada proceeds with stricter enforcement against products without NPNs or ENs, companies can expect a two-stage approach:
- Stage 1—increased enforcement against products without NPNs or ENs upon amending the current compliance and enforcement policies.
- Stage 2—enforcement against all products without NPNs upon the repeal of the UPLAR on February 4, 2013.
While we cannot predict with certainty when the first stage of enforcement will occur, one can reasonably expect that notice to industry will be issued within the next year (likely sooner rather than later). Notwithstanding a regulatory amendment between now and February 4, 2013, it will be illegal to sell unlicensed products as of that date.
While these enforcement changes have not yet occurred, companies should consider the time it will take to launch a new product into the Canadian marketplace both in the short and long term. There remains a backlog in licensing and, even if it is eliminated, can this be it be maintained in the face of new applications?